DRonabinol Treatment of OSA

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 21, 2024

Keywords

ClinConnect Summary

The clinical trial titled "DRonabinol Treatment of OSA" is exploring how effective a medication called Dronabinol is for treating obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. This study will involve adults aged 18 to 65 who have a moderate to severe case of OSA, specifically those with a certain level of breathing interruptions during sleep. Participants will take Dronabinol for two weeks, and their sleep will be monitored before and after treatment to see if their OSA improves.

To join the study, individuals must not be using certain treatments for OSA, such as a continuous positive airway pressure (CPAP) machine or specific devices. Participants will also need to be in good health without severe medical or mental health issues. This trial is not currently recruiting, but once it begins, eligible individuals can expect to take a medication for two weeks and undergo sleep studies to track their progress.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults 18 to 65 years of age.
• • 2. AHI 15-50 per hour on pre-treatment polysomnography.
• Exclusion Criteria:
• • 1. Positive Airway Pressure (PAP) treatment of OSA: use \> 4 hours per day for 30% of days within 3 months of enrollment. PAP use will be determined from device download data.
• • 2. Hypoglossal nerve stimulator (HNS) or oral appliance device treatment with use \> 4 hours per day for 30% of days within 3 months of enrollment. HNS use will be determined by device download and oral appliance use by self-report.
• • 3. History of upper airway surgery for OSA (except adenotonsillectomy).
• • 4. Central or mixed apneas \>25% of respiratory events on diagnostic polysomnography.
• • 5. Arterial oxygen saturation \< 75% for \> 5% sleep time on pretreatment polysomnography.
• • 6. Body mass index \> 45 kg/m2.
• • 7. If post-bariatric surgery, weight must be stable ±5% (per electronic medical records) for at least 6 months before the first dose of the study drug.
• • 8. Active enrollment in a weight loss program.
• • 9. Shiftwork within 3 months of enrollment.
• • 10. High-risk occupation: commercial driver and pilot.
• • 11. Motor vehicle accident or near-miss incident within 1 year of enrollment.
• • 12. Current drug or habitual alcohol use or positive urine drug screen.
• 13. Comorbid medical and psychiatric disorders:
• • 1. Primary sleep disorders: e.g., narcolepsy, restless legs syndrome.
• • 2. Uncontrolled mood disorder or a diagnosis of schizophrenia.
• • 3. Initiation of new antidepressant or antipsychotic medication within 3 months.
• • 4. Identified as high-risk for suicide in electronic health records.
• • 5. Uncontrolled medical disorders (coronary heart disease, arrhythmia, congestive heart failure, chronic obstructive pulmonary disease, chronic hypoxemic or hypercapnic respiratory failure, stroke within 6 months of enrollment, chronic liver or kidney disease, autoimmune disorders).
• • 14. Use of sedative-hypnotic medications within 30 days of enrollment.
• • 15. Complete blood count or liver function test values more than 1.5 times the upper limit of normal.
• • 16. Pregnancy.
• • 17. Allergy to cannabinoids or sesame oil.
• • 18. Average weekly alcohol consumption of more than 10 servings.
• • 19. Participation in other investigational protocols within 30 days of enrollment.